Allergic Conjunctivitis Clinical Trial
The objective of this study is to further evaluate the safety of Olopatadine Ophthalmic Solution 0.1% in Japanese children with allergic conjunctivitis.
Status | Completed |
Enrollment | 42 |
Est. completion date | July 2011 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 7 Years to 15 Years |
Eligibility |
Inclusion Criteria: - Patients whose parents or guardians can issue informed consent - Patients aged over 7 and less than 16 at the baseline - Patients confirmed to show type I allergy - Patients with allergic conjunctivitis - Patients having subjective symptoms at the baseline (itching sensation, foreign body sensation, eye pain, etc.) Exclusion Criteria: - Patients having ocular itching sensation and injection caused by disease other than allergic conjunctivitis - Patients having retinal detachment, diabetic retinopathy or progressive retinal disease - Patients with a history of ocular infection, corneal herpes or relapsing corneal erosion of sudden onset or secondary to corneal injury - Patients having received continuous treatment with corticosteroid within 3 months - Patients having received immunotherapy - Patients requiring continuous treatment of corticosteroid, immunosuppressors, non-steroidal anti-inflammatory agents, vasoconstrictors, anti-histamines, anti-allergy agents, herbal preparations indicated for "conjunctivitis" or any ophthalmic solution other than the test product - Patients having undergone ocular laser therapy within 3 months - Unilaterally blind patients (best corrected visual acuity: below 0.01) - Patients with a history of allergy or hypersensitivity to olopatadine hydrochloride - Patients necessitating the use of contact lens during the study period - Other patients judged by the attending physician as inappropriate for study |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Japan | Contact Alcon Call Center For Trial Locations | Tokyo |
Lead Sponsor | Collaborator |
---|---|
Alcon Research |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of adverse events | 4 weeks | Yes | |
Primary | Questionnaire about compliance with dosing instructions | (1;always >90% 2;often 75-90% 3;sometimes 50-75% 4;seldom <50%) | 4 weeks | No |
Secondary | Changes in score of subjective symptoms and objective findings | (0;none 1;mild 2;moderate 3;severe) | 4 weeks | No |
Secondary | Questionnaire about stinging after instillation | (1;none 2;mild 3;moderate 4;severe) | 4 weeks | No |
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